LIXTE BIOTECHNOLOGY HOLDINGS INC
For the period ended Sep 30, 2024. Filed Nov 12, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 12, 2024
NMAD$3.60+3.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-08.
0001493152-24-030757
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0001493152-24-044810
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 169 previous paragraphs and 189 current paragraphs.
95 unchanged; 57 reworded; 35 added; 17 removed; 0 previous and 2 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (35)
Current report
On September 4, 2024, the Company announced it had received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent application number 16/467,721, titled, “Oxabicycloheptanes for Modulation of Immune Response,” for combining the Company’s lead compound, LB-100, with various innovative cancer immunotherapies.
Current report
Nasdaq Compliance
Current report
On August 19, 2024, the Company received a deficiency letter from the Listing Qualifications Department of Nasdaq indicating that it was not in compliance with Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity Rule”), which requires the Company to maintain a minimum stockholders’ equity of $2,500,000. This notice of non-compliance has no immediate impact on the continued listing or trading of the Company’s securities on Nasdaq, which will continue to be listed and traded on Nasdaq, subject to the Company’s compliance with the other Nasdaq continued listing requirements.
Current report
On October 3, 2024, the Company submitted a letter to Nasdaq with its plan to regain compliance with the Stockholders’ Equity Rule, which outlined the Company’s proposed initiatives to regain compliance by raising equity capital through various registered equity offerings.
Current report
On October 21, 2024, Nasdaq provided the Company notice that it had granted an extension through February 18, 2025 for the Company to regain compliance with the Stockholders’ Equity Rule. The Company must complete its capital raising initiatives and evidence compliance with the Stockholders’ Equity Rule through filing a Current Report on Form 8-K with the SEC providing certain required information by February 18, 2025.
Current report
If the Company fails to evidence compliance with the Stockholders’ Equity Rule upon filing its periodic report for the quarter ending March 31, 2025 with the SEC, the Company may be subject to delisting. If Nasdaq determines to delist the Company’s common stock, the Company will have the right to appeal to a Nasdaq hearings panel. The hearing request would stay any suspension or delisting action pending the conclusion of the hearing process.
Current report
The Company intends to take reasonable measures available to regain compliance under Nasdaq’s listing rules and to remain listed on Nasdaq. However, there can be no assurances that the Company will ultimately regain compliance with the Stockholders’ Equity Rule, or be able to maintain compliance with all other applicable requirements for continued listing on Nasdaq. If the Company does not regain compliance with Nasdaq’s listing rules within the time period permitted by Nasdaq, then the Company’s securities will be delisted from Nasdaq.
Current report
Intellectual Property
Current report
The Company’s intellectual property includes proprietary know-how, proprietary methodologies and extensive clinical validation data and publications. To provide legal protection of the Company’s intellectual property, the Company relies on a combination of patents, licenses, trade secrets, trademarks, confidentiality and non-disclosure clauses and agreements, and other forms of intellectual property protection to define and protect our rights to the Company’s product candidates.
Current report
The Company’s product candidates are expected to be covered by its patents. These patents now cover sole rights to the composition and synthesis of the Company’s LB-100 series of drugs, which is the Company’s lead clinical compound in development. The Company has filed patent applications covering the treatment of cancer with LB-100. The Company has also filed joint patent applications with the NIH and the Netherlands Cancer Institute for the treatment of cancer using LB-100 in combination with other drugs such as an immune checkpoint inhibitor and a WEE1 inhibitor.
Current report
Patent applications for the LB-100 series (oxabicycloheptanes and oxabicycloheptenes) have been filed in the United States and internationally under the Patent Cooperation Treaty. Patents for composition of matter and for several uses of the LB-100 series have been issued in the United States, Mexico, Australia, Japan, China, Hong Kong, Canada, and by the European Patent Office
Current report
The Company strives to protect and enhance the proprietary technology, inventions, and improvements that are commercially important to the development of its business, including seeking, maintaining, and defending its patent rights, which are owned solely by the Company’s wholly-owned Delaware subsidiary, Lixte Biotechnology, Inc., except in several instances jointly with one of the Company’s many collaborators. The Company also relies on trade secrets relating to its proprietary pipeline of product candidates and on know-how and continuing technological innovation to develop and strengthen its pipeline. The Company intend to rely on regulatory protection afforded by regulatory agencies through data exclusivity, market exclusivity, and patent term extensions, where available.
Current report
The Company’s success will depend in large part on its ability to obtain and maintain patent and other proprietary protection for commercially important technology, inventions and know-how related to its business; defend and enforce its patents; preserve the confidentiality of its trade secrets; and operate without infringing valid and enforceable patents or proprietary rights of third parties. The Company’s ability to stop third parties from making, using, selling, offering to sell, or importing its technology may depend on the extent to which the Company has rights under valid and enforceable licenses, patents, or trade secrets that cover these activities. In some cases, enforcement of these rights may depend on cooperation of the joint owners of the Company’s jointly owned patents and patent applications.
Current report
With respect to both the Company’s solely and jointly owned intellectual property, the Company cannot be sure that patents will be granted on any of its pending patent applications or on any patent applications filed solely or jointly by the Company in the future; the Company cannot be sure that any of its existing patents or any patents that may be granted to the Company in the future will be commercially useful in protecting the Company’s intended commercial products or therapeutic methods; and the Company cannot be sure that an agency or court would determine that its solely or jointly owned patents are valid and enforceable.
Current report
The Company’s lead drug candidate, LB-100, is currently undergoing various clinical trials, and there is a risk that one or more of these trials could be placed on hold by regulatory authorities due to serious adverse events (SAEs) related to our drug candidate or to another company’s drug used in combination in one of our clinical trials. It is possible that the SAEs could be attributable to our drug candidate and could include, but not be limited to, unexpected severe side effects, treatment-related deaths, or long-term health complications. A dose given could result in non-tolerable adverse events defined as dose-limiting toxicity (DLT). When two DLTs occur at the same dose-level that dose-level is considered too high and unsafe. Further treatment is only allowed at lower dose-levels that have previously been found safe.
Current report
If an SAE or a pattern of SAEs is observed during the course of a clinical trial involving our drug candidate, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or other regulatory authorities may issue a clinical hold, requiring us to pause or discontinue further enrollment and dosing in our clinical trial. It is also possible that the clinical trial could be terminated. Any of these actions could delay or halt the development of our drug candidate, increase development costs, and negatively impact our ability to ultimately achieve regulatory approval. Additionally, if an SAE is confirmed to be drug-related, we may be required to conduct additional studies, modify the study design, or abandon further development of the drug candidate altogether, which could materially impact our business, financial condition, and prospects.
Current report
The occurrence of an SAE and any resulting clinical hold could also harm our reputation with patients, physicians, health institutions, and investors, diminish our ability to attract clinical trial participants, and damage our ability to interest investors and obtain financing in the future. There can be no assurance that we will not experience such SAEs in the future or that any related clinical hold will be lifted in a timely manner, or at all.
Current report
The principal investigator of the colorectal study testing LB-100 in combination with atezolizumab (Roche PD-L1 inhibitor) is currently investigating two SAEs observed in the clinical trial that was launched in August 2024. Evaluation is underway to determine next steps.
Current report
Other Business Risks
Current report
For the three months ended September 30, 2023, general and administrative costs were $891,694, which consisted of the fair value of vested stock options issued to directors and officers of $112,106 (including quarterly director and board committee fees of $0), patent and licensing legal and filing fees and costs of $178,012, other consulting and professional fees of $199,884, insurance expense of $107,910, officer salaries and related costs of $216,880, cash-based director and board committee fees of $42,228, shareholder reporting costs of $3,887, listing fees of $15,500, filing fees of $4,439, taxes and licenses of $3,946, investor relations of $14,172, rent of $7,323, and other operating costs of $6,914, offset by a credit to licensing and royalties of $21,507 relating to the termination of the Moffitt agreement.
Current report
Research and Development Costs. For the three months ended September 30, 2024, research and development costs were $361,630, which consisted of clinical and related oversight costs of $250,342, regulatory service costs of $11,405, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $99,883.
Current report
Included in clinical and related oversight costs for the three months ended September 30, 2024 is $207,004 for the cost of patients enrolled in the City of Hope clinical trial prior to its termination on July 8, 2024.
Current report
For the three months ended September 30, 2023, research and development costs were $132,487, which consisted of clinical and related oversight costs of $8,816, regulatory service costs of $10,919, and pre-clinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $124,752, offset by a credit of $12,000 relating to the termination of the Moffitt agreement.
Current report
Research and development costs increased by $229,143, or 173.0%, in 2024 as compared to 2023, primarily as a result of a charge of $207,004 for the cost of patients enrolled in the City of Hope clinical trial prior to its termination on July 8, 2024.
Current report
Nine Months Ended September 30, 2024 and 2023
Current report
General and Administrative Costs. For the nine months ended September 30, 2024, general and administrative costs were $2,267,890, which consisted of the fair value of vested stock options issued to directors and officers of $340,445 (including quarterly director and board committee fees of $55,000), patent and licensing legal and filing fees and costs of $192,239, other consulting and professional fees of $510,582, insurance expense of $370,167, officer salaries and related costs of $549,317, cash-based director and board committee fees of $38,819, licensing and royalties of $68,106, shareholder reporting costs of $15,690, listing fees of $37,125, filing fees of $21,917, taxes and licenses of $30,869, investor relations of $48,191, rent of $13,099, conference fees of $14,475 and other operating costs of $16,849.
Current report
For the nine months ended September 30, 2023, general and administrative costs were $3,315,297, which consisted of the fair value of vested stock options issued to directors and officers of $669,146, patent and licensing legal and filing fees and costs of $835,362, other consulting and professional fees of $529,830, insurance expense of $316,214, officer salaries and related costs of $649,483, cash-based director and board committee fees of $127,229, shareholder reporting costs of $64,783, listing fees of $46,500, filing fees of $14,634, taxes and licenses of $11,483, investor relations of $36,516, rent of $11,436, conference fees of $0 and other operating costs of $11,790, offset by a credit to licensing fees of $9,109 relating to the termination of the Moffitt agreement.
Current report
Research and Development Costs. For the nine months ended September 30, 2024, research and development costs were $691,402, which consisted of clinical and related oversight costs of $358,318, regulatory service costs of $14,021, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $319,063.
Current report
Included in clinical and related oversight costs for the nine months ended September 30, 2024 is $207,004 for the cost of patients enrolled in the City of Hope clinical trial prior to its termination on July 8, 2024.
Current report
For the nine months ended September 30, 2023, research and development costs were $749,029, which consisted of clinical and related oversight costs of $390,708, regulatory service costs of $18,738, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $339,583.
Current report
The principal investigator of the colorectal study testing LB-100 in combination with atezolizumab is currently investigating two Serious Adverse Events (“SAEs”) observed in the clinical trial. Evaluation is underway to determine next steps (see “Serious Adverse Events” below for additional information).
Current report
The Company has no financial contractual commitment associated with this clinical trial.
Current report
Costs under this letter of intent and related work order agreement are estimated to be approximately $95,000. During the three months and nine months ended September 30, 2024, the Company incurred costs of $12,610 and $20,838 pursuant to this letter of intent and subsequent work order. As of September 30, 2024, total costs of $20,838 have been incurred pursuant to this letter of intent and subsequent work order.
Current report
The Company is obligated to provide annual reports to the NIH on its progress toward the development and commercialization of products under the licensed patents. These reports, due within sixty days following the end of each calendar year, must include updates on research and development activities, regulatory submissions, manufacturing efforts, sublicensing, and sales initiatives. If any deviations from the established commercial development plan or agreed-upon benchmarks occur, the Company is obligated to provide explanation and may amend the commercial development plan and the benchmarks, which, subject to certain conditions, the NIH shall not unreasonably withhold, condition, or delay approval of any request of the Company to amend the commercial development plan and/or the benchmarks and to extend the time periods of the benchmarks.
Current report
During the three months and nine months ended September 30, 2023, the Company recorded credits to operations of $21,507 and $9,109, respectively, representing the reversal of obligations previously recorded with respect to the Exclusive License Agreement.
Removed paragraphs (17)
Previous report
On May 24, 2024, the Company provided notice to Dr. James Miser that it had elected not to renew the employment agreement between the Company and Dr. Miser pursuant to which Dr. Miser has served as the Company’s Chief Medical Officer since August 1, 2020. Accordingly, such employment expired on July 31, 2024.
Previous report
On May 31, 2024, the Company entered into a Consulting Agreement (the “Schellens Agreement”) with Dr. Jan H.M. Schellens, M.D., Ph.D. Pursuant to the Schellens Agreement, effective July 1, 2024, the Company engaged Dr. Schellens as a consultant, and, effective August 1, 2024, as the Company’s Chief Medical Officer. The term of the Schellens Agreement will be in effect from July 1, 2024 until the earliest of (i) termination by either party upon sixty days’ notice, (ii) Dr. Schellens’ death or disability, or (iii) termination by the Company for breach as provided in the Schellens Agreement. Under the Schellens Agreement, Dr. Schellens will provide his services for two days per week with the specific days in each week to be based on arrangements agreed to from time to time between Dr. Schellens and the Company’s Chief Executive Officer. The Company will pay Dr. Schellens 104,000 Euros on an annual basis.
Previous report
Dr. Schellens will play a leadership role in the planning, implementation and oversight of clinical trials and be responsible for assisting in the development of strategic clinical goals and the implementation and safety monitoring of investigational studies. Dr. Schellens will be the primary medical monitor for all clinical investigational studies, and for the oversight of third party CRO monitors. He will be responsible for the regulatory strategy and implementation of the strategy and the primary contact for regulators. Dr. Schellens will work closely with the Company’s Chief Executive Officer on the development of strategic goals needed to insure the timely implementation of appropriate clinical studies needed for the successful registration of therapeutics products. Dr. Schellens services will be principally rendered in the Netherlands.
Previous report
Dr. Schellens, age 67, has more than 25 years of clinical experience as a medical oncologist, pharmacologist and clinical pharmacologist, including more than two decades developing and bringing new drugs to market. Co-author of more than 900 publications in peer-reviewed scientific journals, Dr. Schellens has held leadership positions at the Netherlands Cancer Institute in Amsterdam and the Dr. Daniel den Hoed Clinic-Erasmus University in Rotterdam. He was professor of clinical pharmacology at Utrecht University in the Netherlands, where he earned his M.D. degree, and he served as a board member and Chief Medical Officer of Byondis B.V. from January 2019 through September 2023. He also earned a Ph.D. degree in Pharmaceutical Sciences from Leiden University in Leiden, Netherlands. Dr. Schellens served for 17 years as a board member of the Dutch Medicines Evaluation Board and for 12 years as a member and chairperson of the Scientific Advisory Board Oncology of the EMA. From 2016 to the present, he has served as a part-time Chief Medical Officer of Modra Pharmaceuticals B.V., an Amsterdam-based company that successfully completed a Phase 2b clinical study of ModraDoc006/r, a boosted oral taxane therapeutic, in contrast to the standard-of-care IV chemotherapy docetaxel, in patients with prostate cancer.
Previous report
Nasdaq Listing
Previous report
For the three months ended June 30, 2023, general and administrative costs were $1,242,541, which consisted of the fair value of vested stock options issued to directors and officers of $280,060, patent and licensing legal and filing fees and costs of $340,010, other consulting and professional fees of $159,361, insurance expense of $104,151, officer salaries and related costs of $216,248, cash-based director and board committee fees of $42,501, licensing and royalties of $6,233, shareholder reporting costs of $57,350, listing fees of $15,500, filing fees of $3,470, taxes and licenses of $3,769, investor relations of $9,372, rent of $1,530, conference fees of $0 and other operating costs of $2,986.
Previous report
Research and Development Costs. For the three months ended June 30, 2024, research and development costs were $210,708, which consisted of clinical and related oversight costs of $97,947, regulatory service costs of $1,956, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $110,805.
Previous report
For the three months ended June 30, 2023, research and development costs were $427,457, which consisted of clinical and related oversight costs of $297,763, regulatory service costs of $1,740, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $127,954.
Previous report
Research and development costs decreased by $216,749, or 50.7%, in 2024 as compared to 2023, as a result of a decrease in clinical and related oversight costs of $199,816, and a decrease in preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $17,149.
Previous report
Six Months Ended June 30, 2024 and 2023
Previous report
General and Administrative Costs. For the six months ended June 30, 2024, general and administrative costs were $1,646,263, which consisted of the fair value of vested stock options issued to directors and officers of $233,618 (including quarterly director and board committee fees of $27,500), patent and licensing legal and filing fees and costs of $146,823, other consulting and professional fees of $363,972, insurance expense of $253,727, officer salaries and related costs of $387,589, cash-based director and board committee fees of $38,819, licensing and royalties of $60,569, shareholder reporting costs of $12,749, listing fees of $24,750, filing fees of $19,053, taxes and licenses of $30,813, investor relations of $34,794, rent of $9,881, conference fees of $14,475 and other operating costs of $14,631.
Previous report
For the six months ended June 30, 2023, general and administrative costs were $2,423,603, which consisted of the fair value of vested stock options issued to directors and officers of $557,040, patent and licensing legal and filing fees and costs of $657,350, other consulting and professional fees of $329,946, insurance expense of $208,305, officer salaries and related costs of $432,603, cash-based director and board committee fees of $85,001, licensing and royalties of $12,398, shareholder reporting costs of $60,896, listing fees of $31,000, filing fees of $10,195, taxes and licenses of $7,538, investor relations of $22,344, rent of $4,113, conference fees of $0 and other operating costs of $4,874.
Previous report
Research and Development Costs. For the six months ended June 30, 2024, research and development costs were $329,772, which consisted of clinical and related oversight costs of $107,976, regulatory service costs of $2,616, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $219,180.
Previous report
For the six months ended June 30, 2023, research and development costs were $616,542, which consisted of clinical and related oversight costs of $393,892, regulatory service costs of $7,819, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $214,831.
Previous report
As of June 30, 2024, no costs have been incurred pursuant to this agreement.
Previous report
This letter of intent is designed to serve as a statement of the intent to retain the oversight services of Theradex with respect to the MD Andersen clinical trial at an additional cost of approximately $72,000.
Previous report
During the three months and six months ended June 30, 2023, the Company recorded charges to operations of $6,233 and $12,398, respectively, in connection with its obligations under the License Agreement.
Reworded paragraphs (57)
Previous wording
For the six months ended June 30, 2024, the Company recorded a net loss of $1,982,241 and used cash in operations of $1,608,266. At June 30, 2024, the Company had cash of $2,595,222 available to fund its operations. Because the Company is currently engaged in various early-stage clinical trials, it is expected that it will take a significant amount of time and resources to develop any product or intellectual property capable of generating sustainable revenues. Accordingly, the Company’s business is unlikely to generate any sustainable operating revenues in the next several years and may never do so. Even if the Company is able to generate revenues through licensing its technology, product sales or other commercial activities, there can be no assurance that the Company will be able to achieve and maintain positive earnings and operating cash flows. At June 30, 2024, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated approximately $3,614,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Current wording
For the nine months ended September 30, 2024, the Company recorded a net loss of $2,968,271 and used cash in operations of $2,565,861. At September 30, 2024, the Company had cash of $1,637,627 available to fund its operations. Because the Company is currently engaged in various early-stage clinical trials, it is expected that it will take a significant amount of time and resources to develop any product or intellectual property capable of generating sustainable revenues. Accordingly, the Company’s business is unlikely to generate any sustainable operating revenues in the next several years and may never do so. Even if the Company is able to generate revenues through licensing its technology, product sales or other commercial activities, there can be no assurance that the Company will be able to achieve and maintain positive earnings and operating cash flows. At September 30, 2024, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated approximately $3,918,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Previous wording
Based on current operating plans, the Company estimates that its existing cash resources at June 30, 2024 will provide sufficient working capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound, LB-100, through approximately December 31, 2024. As existing cash resources will not be sufficient to complete the clinical development of, and obtain regulatory approval for, the Company’s product candidate, the Company will need to raise additional capital in one or more tranches to fund its operations in the near-term in order to be able to effectively manage its current business plan during the remainder of 2024, the full year 2025, and thereafter. In addition, the Company’s operating plans and capital requirements may change as a result of many factors that are currently unknown and/or outside of the control of the Company. The Company is considering various strategies and alternatives to obtain the required additional capital.
Current wording
Based on current operating plans, the Company estimates that its existing cash resources at September 30, 2024 will provide sufficient working capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound, LB-100, through the first quarter of 2025. As existing cash resources will not be sufficient to complete the clinical development of, and obtain regulatory approval for, the Company’s product candidate, the Company will need to raise additional capital in one or more tranches to fund its operations during the next few months in order to be able to effectively manage its current business plan during 2025 and thereafter, as well as to maintain its listing on Nasdaq. Furthermore, the Company’s operating plans and capital requirements may change as a result of many factors that are currently unknown and/or outside of the control of the Company. The Company is considering various strategies and alternatives to obtain the required additional capital.
Previous wording
The Company’s common stock and the warrants are traded on the Nasdaq Capital Market (“Nasdaq”) under the symbols “LIXT” and “LIXTW”, respectively. On June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock in order to remain in compliance with the $1.00 minimum closing bid price requirement of Nasdaq. However, there can be no assurances that the Company will be able to remain in compliance with the $1.00 minimum closing bid price requirement of Nasdaq over time. In addition, Nasdaq has other continued listing requirements, one of which is maintaining a minimum net stockholders’ equity of $2,500,000. At June 30, 2024, the Company’s net stockholders equity was $2,246,139.
Current wording
The Company’s common stock and the warrants are traded on the Nasdaq Capital Market (“Nasdaq”) under the symbols “LIXT” and “LIXTW”, respectively. On June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock in order to remain in compliance with the $1.00 minimum closing bid price requirement of Nasdaq. However, there can be no assurances that the Company will be able to remain in compliance with the $1.00 minimum closing bid price requirement of Nasdaq over time. In addition, Nasdaq has other continued listing requirements, one of which is maintaining a minimum net stockholders’ equity of $2,500,000.
Previous wording
Information with respect to recent accounting pronouncements is provided at Note 2 to the condensed consolidated financial statements for the three months and six months ended June 30, 2024 and 2023 included elsewhere in this document.
Current wording
Information with respect to recent accounting pronouncements is provided at Note 2 to the condensed consolidated financial statements for the three months and nine months ended September 30, 2024 and 2023 included elsewhere in this document.
Previous wording
Information with respect to concentration of risk is provided at Note 2 to the condensed consolidated financial statements for the three months and six months ended June 30, 2024 and 2023 included elsewhere in this document.
Current wording
Information with respect to concentration of risk is provided at Note 2 to the condensed consolidated financial statements for the three months and nine months ended September 30, 2024 and 2023 included elsewhere in this document.
Previous wording
During the three months ended June 30, 2024 and 2023, patent and licensing legal and filing fees and costs related to the development and protection of its intellectual property were $63,612 and $340,010, respectively, a decrease of $276,398, or 81.3%, in 2024 as compared to 2023.
Current wording
During the three months ended September 30, 2024 and 2023, patent and licensing legal and filing fees and costs related to the development and protection of its intellectual property were $45,416 and $178,012, respectively, a decrease of $132,596, or 74.5%, in 2024 as compared to 2023.
Previous wording
During the six months ended June 30, 2024 and 2023, patent and licensing legal and filing fees and costs related to the development and protection of its intellectual property were $146,823 and $657,350, respectively, a decrease of $510,527, or 77.7%, in 2024 as compared to 2023.
Current wording
During the nine months ended September 30, 2024 and 2023, patent and licensing legal and filing fees and costs related to the development and protection of its intellectual property were $192,239 and $835,362, respectively, a decrease of $643,123, or 77.0%, in 2024 as compared to 2023.
Previous wording
The Company is focusing its development activities on its LB-100 series of drugs. The Company believes that the mechanism by which compounds of the LB-100 series affect cancer cell growth is different from cancer agents currently approved for clinical use. Lead compounds of the LB-100 series have activity against a broad spectrum of common and rarer human cancers in cell culture systems. In addition, lead compounds of the LB-100 series have anti-cancer activity in animal models of glioblastoma multiforme, neuroblastoma, and medulloblastoma, all cancers of neural tissue. Lead compounds of the LB-100 series also have activity against melanoma, breast cancer and sarcoma in animal models and enhance the effectiveness of commonly used anti-cancer drugs in these animal models. The enhancement of anti-cancer activity of these anti-cancer drugs occurs at doses of LB-100 that do not significantly increase toxicity in animals. It is therefore hoped that, when combined with standard anti-cancer regimens against many tumor types, the Company’s compounds will improve therapeutic benefit without unacceptable toxicity in humans. The Company is not currently planning to allocate resources to further develop its LB-200 series of drugs,
Current wording
The Company is focusing its development activities on its lead compound LB-100. The Company believes that the mechanism by which LB-100 affects cancer cell growth is different from cancer agents currently approved for clinical use. LB-100 is currently being tested in clinical trials in Ovarian Clear Cell Carcinoma, Metastatic Micro Satellite Stable (MSS) Colon Cancer and Advanced Soft Tissue Sarcoma. LB-100 has shown anti-cancer activity in animal models of glioblastoma multiforme, neuroblastoma, and medulloblastoma, all cancers of neural tissue. LB-100 enhances the effectiveness of commonly used anti-cancer drugs in melanoma, breast cancer and sarcoma animal models. The enhancement of anti-cancer activity of these anti-cancer drugs occurs at doses of LB-100 that do not significantly increase toxicity in animals. It is therefore hoped that, when combined with standard anti-cancer regimens against many tumor types, LB-100 will improve therapeutic benefit.
Previous wording
External Risks Associated with the Company’s Business Activities
Current wording
Specific Risks Associated with the Company’s Business Activities
Previous wording
Covid-19 Virus. The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughout the world as businesses and governments implemented broad actions to mitigate this public health crisis. Although Covid-19 outbreak has subsided, the extent to which the coronavirus pandemic may reappear and impact the Company’s clinical trial programs and capital raising efforts in the future is uncertain and cannot be predicted.
Current wording
Covid-19 Virus. The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughout the world as businesses and governments implemented broad actions to mitigate this public health crisis. Although Covid-19 outbreak has subsided, the extent to which the coronavirus or any other pandemics may reappear and impact the Company’s clinical trial programs and capital raising efforts in the future is uncertain and cannot be predicted.
Previous wording
General and Administrative Costs. For the three months ended June 30, 2024, general and administrative costs were $798,448, which consisted of the fair value of vested stock options issued to directors and officers of $130,691 (including quarterly director and board committee fees of $27,500), patent and licensing legal and filing fees and costs of $63,612, other consulting and professional fees of $191,529, insurance expense of $126,873, officer salaries and related costs of $191,971, cash-based director and board committee fees of $0, licensing and royalties of $7,455, shareholder reporting costs of $3,811, listing fees of $12,375, filing fees of $11,319, taxes and licenses of $15,406, investor relations of $17,397, rent of $4,230, conference fees of $14,475 and other operating costs of $7,304.
Current wording
General and Administrative Costs. For the three months ended September 30, 2024, general and administrative costs were $621,627, which consisted of the fair value of vested stock options issued to directors and officers of $106,827 (including quarterly director and board committee fees of $27,500), patent and licensing legal and filing fees and costs of $45,416, other consulting and professional fees of $146,610, insurance expense of $116,440, officer salaries and related costs of $161,728, cash-based director and board committee fees of $0, licensing and royalties of $7,537, shareholder reporting costs of $2,941, listing fees of $12,375, filing fees of $2,864, taxes and licenses of $56, investor relations of $13,397, rent of $3,218, and other operating costs of $2,218.
Previous wording
General and administrative costs decreased by $444,093, or 35.7%, in 2024 as compared to 2023, primarily as a result of a decrease in the fair value of vested stock options issued to directors and officers of $149,369, a decrease in patent and licensing legal and filing fees and costs of $276,398, a decrease in shareholder reporting of $53,539, a decrease in officer salaries and related costs of $24,277, and a decrease in cash-based director and board committee fees of $42,501, offset by increases in other consulting and professional fees of $32,168, and an increase in insurance expense of $22,722.
Current wording
General and administrative costs decreased by $270,067, or 30.3%, in 2024 as compared to 2023, primarily as a result of a decrease in the fair value of vested stock options issued to directors and officers of $5,279, a decrease in patent and licensing legal and filing fees and costs of $132,596, a decrease in officer salaries and related costs of $55,152, a decrease in cash-based director and board committee fees of $42,228, and a decrease in other consulting and professional fees of $53,274, offset by an increase in licensing and royalties of $29,044.
Previous wording
Effective June 10, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute (“NKI”) to conduct a Phase 1b/2 clinical trial of the Company’s protein phosphatase inhibitor, LB-100, combined with atezolizumab, a PD-L1 inhibitor, the proprietary molecule of F. Hoffman-La Roche Ltd. (“Roche”), for patients with metastatic colon cancer. NKI employs Dr. René Bernards, a director of the Company since June 15, 2022. As of June 30, 2024, no costs have been incurred pursuant to this clinical trial agreement.
Current wording
Effective June 10, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute (“NKI”) to conduct a Phase 1b/2 clinical trial of the Company’s protein phosphatase inhibitor, LB-100, combined with atezolizumab, a PD-L1 inhibitor, the proprietary molecule of F. Hoffman-La Roche Ltd. (“Roche”), for patients with metastatic colon cancer. NKI employs Dr. René Bernards, a director of the Company since June 15, 2022. The Company has no financial contractual commitment associated with this clinical trial.
Previous wording
Included in preclinical research costs for the three months ended June 30, 2024 and 2023 were $67,119 and $53,178, respectively, of costs paid to the Netherlands Cancer Institute, On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.
Current wording
Included in preclinical research costs for the three months ended September 30, 2024 and 2023 were $76,278 and $51,568, respectively, of costs paid to the Netherlands Cancer Institute, On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.
Previous wording
Interest Income. For the three months ended June 30, 2024, the Company had interest income of $2,233, as compared to interest income of $2,714 for the three months ended June 30, 2023, related to the investment of the Company’s cash resources.
Current wording
Interest Income. For the three months ended September 30, 2024, the Company had interest income of $1,437, as compared to interest income of $5,809 for the three months ended September 30, 2023, related to the investment of the Company’s cash resources.
Previous wording
Interest Expense. For the three months ended June 30, 2024, the Company had interest expense of $4,154, as compared to interest expense of $1,948 for the three months ended June 30, 2023, related to the financing of the premium for the Company’s directors and officers liability insurance policy.
Current wording
Interest Expense. For the three months ended September 30, 2024, the Company had interest expense of $1,049, as compared to interest expense of $279 for the three months ended September 30, 2023, related to the financing of the premium for the Company’s directors and officers liability insurance policy.
Previous wording
Foreign Currency Gain. For the three months ended June 30, 2024, the Company had a foreign currency gain of $158, as compared to a foreign currency gain of $877 for the three months ended June 30, 2023, from foreign currency transactions.
Current wording
Foreign Currency Loss. For the three months ended September 30, 2024, the Company had a foreign currency loss of $3,161, as compared to a foreign currency loss of $109 for the three months ended September 30, 2023, from foreign currency transactions.
Previous wording
Net Loss. For the three months ended June 30, 2024, the Company incurred a net loss of $1,010,919, as compared to a net loss of $1,668,355 for the three months ended June 30, 2023.
Current wording
Net Loss. For the three months ended September 30, 2024, the Company incurred a net loss of $986,030, as compared to a net loss of $1,018,760 for the three months ended September 30, 2023.
Previous wording
Revenues. The Company did not have any revenues for the six months ended June 30, 2024 and 2023.
Current wording
Revenues. The Company did not have any revenues for the nine months ended September 30, 2024 and 2023.
Previous wording
General and administrative costs decreased by $777,340, or 32.1%, in 2024 as compared to 2023, primarily as a result of a decrease in the fair value of vested stock options issued to directors and officers of $323,422, a decrease in patent and licensing legal and filing fees and costs of $510,527, a decrease in shareholder reporting costs of $48,147, a decrease in officer salaries and related costs of $45,014, and a decrease in cash-based director and board committee fees of $46,182, offset by increases in other consulting and professional fees of $34,026, licensing and royalties of $48,171, taxes and licenses of $23,275, investor relations of $12,450, conference fees of $14,475, and an increase in insurance expense of $45,422.
Current wording
General and administrative costs decreased by $1,047,407, or 31.6%, in 2024 as compared to 2023, primarily as a result of a decrease in the fair value of vested stock options issued to directors and officers of $328,701, a decrease in patent and licensing legal and filing fees and costs of $643,123, a decrease in shareholder reporting costs of $49,093, a decrease in officer salaries and related costs of $100,166, and a decrease in cash-based director and board committee fees of $88,410, offset by increases in licensing and royalties of $77,215, taxes and licenses of $19,386, and in insurance expense of $53,953.
Previous wording
Effective June 10, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute (“NKI”) to conduct a Phase 1b/2 clinical trial of the Company’s protein phosphatase inhibitor, LB-100, combined with atezolizumab, a PD-L1 inhibitor, the proprietary molecule of F. Hoffman-La Roche Ltd. (“Roche”), for patients with metastatic colon cancer. NKI employs Dr. René Bernards, a director of the Company since June 15, 2022. As of June 30, 2024, no costs have been incurred pursuant to this clinical trial agreement.
Current wording
Effective June 10, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute (“NKI”) to conduct a Phase 1b/2 clinical trial of the Company’s protein phosphatase inhibitor, LB-100, combined with atezolizumab, a PD-L1 inhibitor, the proprietary molecule of F. Hoffman-La Roche Ltd. (“Roche”), for patients with metastatic colon cancer. NKI employs Dr. René Bernards, a director of the Company since June 15, 2022. The Company has no financial contractual commitment associated with this clinical trial.
Previous wording
Included in preclinical research costs for the six months ended June 30, 2024 and 2023 were $134,084 and $105,382, respectively, of costs paid to the Netherlands Cancer Institute, On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.
Current wording
Included in preclinical research costs for the nine months ended September 30, 2024 and 2023 were $210,362 and $156,950, respectively, of costs paid to the Netherlands Cancer Institute, On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.
Previous wording
Research and development costs decreased by $286,770, or 46.5%, in 2024 as compared to 2023, primarily as a result of a decrease in clinical and related oversight costs of $285,916.
Current wording
Research and development costs decreased by $57,627, or 7.7%, in 2024 as compared to 2023, primarily as a result of a decrease in clinical and related oversight costs of $32,390.
Previous wording
Interest Income. For the six months ended June 30, 2024, the Company had interest income of $5,092, as compared to interest income of $7,729 for the six months ended June 30, 2023, related to the investment of the Company’s cash resources.
Current wording
Interest Income. For the nine months ended September 30, 2024, the Company had interest income of $6,529, as compared to interest income of $13,538 for the nine months ended September 30, 2023, related to the investment of the Company’s cash resources.
Previous wording
Interest Expense. For the six months ended June 30, 2024, the Company had interest expense of $11,340, as compared to interest expense of $5,809 for the six months ended June 30, 2023, related to the financing of the premium for the Company’s directors and officers liability insurance policy.
Current wording
Interest Expense. For the nine months ended September 30, 2024, the Company had interest expense of $12,389, as compared to interest expense of $6,088 for the nine months ended September 30, 2023, related to the financing of the premium for the Company’s directors and officers liability insurance policy.
Previous wording
Foreign Currency Gain. For the six months ended June 30, 2024, the Company had a foreign currency gain of $42, as compared to a foreign currency gain of $2,211 for the six months ended June 30, 2023, from foreign currency transactions.
Current wording
Foreign Currency Gain (Loss). For the nine months ended September 30, 2024, the Company had a foreign currency loss of $3,119, as compared to a foreign currency gain of $2,102 for the nine months ended September 30, 2023, from foreign currency transactions.
Previous wording
Net Loss. For the six months ended June 30, 2024, the Company incurred a net loss of $1,982,241, as compared to a net loss of $3,036,014 for the six months ended June 30, 2023.
Current wording
Net Loss. For the nine months ended September 30, 2024, the Company incurred a net loss of $2,968,271, as compared to a net loss of $4,054,774 for the nine months ended September 30, 2023.
Previous wording
At June 30, 2024, the Company had working capital of $2,246,139, as compared to working capital of $3,994,762 at December 31, 2023, reflecting a decrease in working capital of $1,748,623 for the six months ended June 30, 2024. The decrease in working capital during the six months ended June 30, 2024 was primarily the result of the funding of the Company’s ongoing research and development activities and other ongoing operating expenses, including maintaining and developing the Company’s patent portfolio. At June 30, 2024, the Company had cash of $2,595,222 available to fund its operations.
Current wording
At September 30, 2024, the Company had working capital of $1,360,008, as compared to working capital of $3,994,762 at December 31, 2023, reflecting a decrease in working capital of $2,634,754 for the nine months ended September 30, 2024. The decrease in working capital during the nine months ended September 30, 2024 was primarily the result of the funding of the Company’s ongoing research and development activities and other ongoing operating expenses, including maintaining and developing the Company’s patent portfolio. At September 30, 2024, the Company had cash of $1,637,627 available to fund its operations.
Previous wording
Based on current operating plans, the Company estimates that its existing cash resources at June 30, 2024 will provide sufficient working capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound, LB-100, through approximately December 31, 2024. As existing cash resources will not be sufficient to complete the clinical development of, and obtain regulatory approval for, the Company’s product candidate, the Company will need to raise additional capital in one or more tranches to fund its operations in the near-term in order to be able to effectively manage its current business plan during the remainder of 2024, the full year 2025, and thereafter. In addition, the Company’s operating plans and capital requirements may change as a result of many factors that are currently unknown and/or outside of the control of the Company. The Company is considering various strategies and alternatives to obtain the required additional capital.
Current wording
Based on current operating plans, the Company estimates that its existing cash resources at September 30, 2024 will provide sufficient working capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound, LB-100, through the first quarter of 2025. As existing cash resources will not be sufficient to complete the clinical development of, and obtain regulatory approval for, the Company’s product candidate, the Company will need to raise additional capital in one or more tranches to fund its operations during the next few months in order to be able to effectively manage its current business plan during 2025 and thereafter, as well as to maintain its listing on Nasdaq. Furthermore, the Company’s operating plans and capital requirements may change as a result of many factors that are currently unknown and/or outside of the control of the Company. The Company is considering various strategies and alternatives to obtain the required additional capital.
Previous wording
At June 30, 2024, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated $3,614,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Current wording
At September 30, 2024, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated $3,918,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Previous wording
Operating Activities. For the six months ended June 30, 2024, operating activities utilized cash of $1,608,266, as compared to utilizing cash of $2,446,753 for the six months ended June 30, 2023, to fund the Company’s ongoing research and development activities and to fund its other ongoing operating expenses, including maintaining and developing its patent portfolio.
Current wording
Operating Activities. For the nine months ended September 30, 2024, operating activities utilized cash of $2,565,861, as compared to utilizing cash of $3,391,142 for the nine months ended September 30, 2023, to fund the Company’s ongoing research and development activities and to fund its other ongoing operating expenses, including maintaining and developing its patent portfolio.
Previous wording
Investing Activities. For the six months ended June 30, 2024 and 2023, the Company had no investing activities.
Current wording
Investing Activities. For the nine months ended September 30, 2024 and 2023, the Company had no investing activities.
Previous wording
Financing Activities. For the six months ended June 30, 2024, the Company had no financing activities. For the six months ended June 30, 2023, financing activities consisted of $6,281 from the exercise of common stock options.
Current wording
Financing Activities. For the nine months ended September 30, 2024, the Company had no financing activities. For the nine months ended September 30, 2023, financing activities consisted primarily of the gross proceeds from the sale of securities in the Company’s registered direct offering of $3,499,964, reduced by offering costs of $362,925, and $6,281 from the exercise of common stock options.
Previous wording
At June 30, 2024, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred, as described below, aggregated $3,614,000, including clinical trial agreements of $3,467,000 and clinical trial monitoring agreements of $147,000, which, based on current estimates, are currently scheduled to be incurred through approximately December 31, 2027. The Company’s ability to conduct and fund these contractual commitments is subject to the timely availability of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation of such funds to the Company’s current or future clinical trial programs. The Company expects that the full amount of these expenditures will be incurred only if such clinical trial programs are conducted as originally designed and their respective enrollments and duration are not modified or reduced. Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can frequently involve a series of changes and modifications over time as clinical data is obtained and analyzed, and is frequently modified, suspended or terminated, in part based on receipt or lack of receipt of an indication of clinical benefit or activity, before the clinical trial endpoint is reached. Accordingly, such contractual commitments as discussed herein should be considered as estimates only based on current clinical assumptions and conditions and are typically subject to significant modifications and revisions over time.
Current wording
At September 30, 2024, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred, as described below, aggregated $3,918,000, including clinical trial agreements of $3,616,000 and clinical trial monitoring agreements of $302,000, which, based on current estimates, are currently scheduled to be incurred through approximately December 31, 2027. The Company’s ability to conduct and fund these contractual commitments is subject to the timely availability of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation of such funds to the Company’s current or future clinical trial programs. The Company expects that the full amount of these expenditures will be incurred only if such clinical trial programs are conducted as originally designed and their respective enrollments and duration are not modified or reduced. Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can frequently involve a series of changes and modifications over time as clinical data is obtained and analyzed, and is frequently modified, suspended or terminated, in part based on receipt or lack of receipt of an indication of clinical benefit or activity, before the clinical trial endpoint is reached. Accordingly, such contractual commitments as discussed herein should be considered as estimates only based on current clinical assumptions and conditions and are typically subject to significant modifications and revisions over time.
Previous wording
This study comprises a dose escalation phase and a dose expansion phase. The objective of the dose escalation phase is to determine the recommended Phase 2 dose (RP2D) of LB-100 when combined with the standard dosage of atezolizumab. The dose expansion phase will further investigate the preliminary efficacy, safety, tolerability, and pharmacokinetics/dynamics of the LB-100 and atezolizumab combination. The clinical trial is scheduled to open by September 30, 2024. Patient accrual is expected to take up to 24 months, with a maximum of 37 patients with advanced colorectal cancer to be enrolled in this study.
Current wording
This study comprises a dose escalation phase and a dose expansion phase. The objective of the dose escalation phase is to determine the recommended Phase 2 dose (RP2D) of LB-100 when combined with the standard dosage of atezolizumab. The dose expansion phase will further investigate the preliminary efficacy, safety, tolerability, and pharmacokinetics/dynamics of the LB-100 and atezolizumab combination. The clinical trial opened in August 2024 with the enrollment of the first patient. Patient accrual is expected to take up to 24 months, with a maximum of 37 patients with advanced colorectal cancer to be enrolled in this study.
Previous wording
After evaluating patient accrual through June 30, 2024, the Company and City of Hope agreed to close the clinical trial. Pursuant to the terms of the Agreement, the Company provided notice to City of Hope of the Company’s intent to terminate the Agreement effective as of July 8, 2024. The Company is exploring alternative sites, including international locations, for the conduct of a small cell lung cancer clinical trial.
Current wording
After evaluating patient accrual through June 30, 2024, the Company and City of Hope agreed to close the clinical trial. Pursuant to the terms of the Agreement, the Company provided notice to City of Hope of the Company’s intent to terminate the Agreement effective as of July 8, 2024. Upon closure, the Company incurred a prorated charge of $207,004 for the cost of patients enrolled to date. The Company is exploring alternative sites, including international locations, for the conduct of a small cell lung cancer clinical trial.
Previous wording
During the three months ended June 30, 2024 and 2023, the Company incurred costs of $78,015 and $0, respectively, pursuant to this Agreement. During the six months ended June 30, 2024 and 2023, the Company incurred costs of $78,015 and $69,001, respectively, pursuant to this Agreement. As of June 30, 2024, total costs of $525,528 had been incurred pursuant to this Agreement.
Current wording
During the three months ended September 30, 2024 and 2023, the Company incurred costs of $207,004 and $0, respectively, pursuant to this Agreement. During the nine months ended September 30, 2024 and 2023, the Company incurred costs of $285,019 and $69,001, respectively, pursuant to this Agreement. As of September 30, 2024, total costs of $732,532 had been incurred pursuant to this Agreement.
Previous wording
On October 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios or “AEMPS”) had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of ASTS. Consequently, this clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report prepared by December 31, 2026. In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at Fundación Jiménez Díaz University Hospital (Madrid). Up to 170 patents will be entered into the clinical trial. The recruitment for the Phase 1b portion of the protocol was completed during the quarter ended June 30, 2024. The Company expects to have data on toxicity and preliminary efficacy from this portion of the clinical trial in the quarter ending December 31, 2024, and subject to clinical results and the availability of working capital resources, anticipates that it will then be in a position to decide whether to proceed to the related Phase 2 portion of the study.
Current wording
On October 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios or “AEMPS”) had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of ASTS. Consequently, this clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report prepared by December 31, 2026. In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at Fundación Jiménez Díaz University Hospital (Madrid). Up to 170 patents will be entered into the clinical trial. The recruitment for the Phase 1b portion of the protocol was extended with two patients and was completed during the quarter ended September 30, 2024. The Company expects to have data on toxicity and preliminary efficacy from this portion of the clinical trial by December 31, 2024, and a full report by June 30, 2025. Subject to clinical results and the availability of sufficient working capital resources, the Company anticipates that it will then be in a position to decide whether to proceed to the related Phase 2 portion of the study.
Previous wording
The Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement. During the three months ended June 30, 2024 and 2023, the Company incurred costs of $0 and $268,829, respectively, pursuant to this agreement. During the six months ended June 30, 2024 and 2023, the Company incurred costs of $0 and $268,829, respectively, pursuant to this agreement. Through June 30, 2024, the Company has incurred charges of $684,652 for work done under this agreement through the fourth milestone.
Current wording
The Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement. During the three months ended September 30, 2024 and 2023, the Company did not incur any costs pursuant to this agreement. During the nine months ended September 30, 2024 and 2023, the Company incurred costs of $0 and $268,829, respectively, pursuant to this agreement. Through September 30, 2024, the Company has incurred charges of $684,652 for work done under this agreement through the fourth milestone.
Previous wording
The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $3,467,000 (consisting of $267,000 for the Phase 1b portion and $3,200,000 for the Phase 2 portion) as of June 30, 2024, which is scheduled to be incurred through December 31, 2027. As the work is being conducted in Europe and is paid for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro. Such fluctuations are recorded in the consolidated statements of operations as foreign currency gain or loss, as appropriate, and have not been significant.
Current wording
The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $3,616,000 (consisting of $284,000 for the Phase 1b portion and $3,332,000 for the Phase 2 portion) as of September 30, 2024, which is scheduled to be incurred through December 31, 2027. As the work is being conducted in Europe and is paid for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro. Such fluctuations are recorded in the consolidated statements of operations as foreign currency gain or loss, as appropriate, and have not been significant.
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Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Costs under this work order agreement are estimated to be approximately $106,380, with such payments expected to be allocated approximately 47% to Theradex for services and approximately 53% for payments for pass-through software costs. During the three months and nine months ended September 30, 2024, the Company incurred costs of $14,900 pursuant to this work order. As of September 30, 2024, total costs of $14,900 have been incurred pursuant to this work order agreement.
Current report — wording carried from elsewhere
The Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled approximately $106,380 as of September 30, 2024, which is expected to be incurred through May 31, 2027.